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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) + AiRuiKang (dalpiciclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer
Excerpt:
...- HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline)....
Trial ID:
Source:
Title:
Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer
Excerpt:
...- HER2 positivity is defined by standard of 3+ staining by immunohistochemical staining (IHC) or positive for in situ hybridization (ISH)...
Trial ID:
More C2 evidence
Source:
Title:
Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer
Excerpt:
...- HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline)....
Trial ID:
Source:
Title:
A single-arm, double-cohort, prospective, open-label, phase II exploratory study evaluating dalpiciclib combined with pyrotinib maleate in first-line treatment of HER2+ advanced breast cancer
Excerpt:
...Follow the 2018 ASCO-CAP HER2 positive Interpretation guidelines. ...
Trial ID:
Less C2 evidence
Source:
Title:
Dalpiciclib and pyrotinib in women with HER2-positive advanced breast cancer: a single-arm phase II trial
Published date:
10/07/2023
Excerpt:
In this phase 2 study (NCT04293276), we aim to evaluate a dual-oral regimen of CDK4/6 inhibitor dalpiciclib combined with HER2 tyrosine kinase inhibitor pyrotinib as front-line treatment in women with HER2-positive advanced BC...With a median follow-up of 25.9 months, 70% (28/40) of assessable patients have a confirmed objective response, meeting the primary endpoint. The median PFS is 11.0 months (95% CI = 7.3–19.3...
DOI:
10.1038/s41467-023-41955-7
Trial ID:
Source:
Title:
Updated results from a phase 2 study on dalpiciclib and pyrotinib, a dual-oral chemotherapy-free regimen in HER2-positive advanced breast cancer (DAP-HER-01).
Published date:
05/25/2023
Excerpt:
With a median follow-up of 19.2 months, the median progression-free survival (PFS) was 11.0 months (95% CI 7.3-19.3)….Combined with previous reports, our findings suggest dalpiciclib combined with pyrotinib achieved promising efficacy and manageable toxicity in the treatment of HER2-positive ABC, including patients with HR-negative disease or brain metastases. This combination could be considered as a completely oral, chemo-free regimen for patients with HER2-positive ABC...
DOI:
10.1200/JCO.2023.41.16_suppl.1045
Trial ID:
Source:
Title:
276P - Dalpiciclib, a novel CDK4/6 inhibitor, combined with pyrotinib for HER2+ advanced breast cancer: Interim results of a phase II trial
Published date:
09/13/2021
Excerpt:
In the single-arm, phase II study, HER2+ advanced BC pts who had received no more than 1 line of systemic therapy in advanced setting were recruited. Prior CDK4/6 inhibitors and HER2 targeted TKI were not allowed. Eligible pts received dalpiciclib 125 mg daily for 3 weeks and 1 week off, and pyrotinib 400 mg daily in 28-day cycles....As of April 13th, 2021, of 23 evaluable pts 65.2% (15/23) had achieved confirmed ORR (15PR, 6SD, 2PD)....Dalpiciclib combined with pyrotinib was associated with promising efficacy...
Trial ID:
